Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00311246 · ClinicalTrials.gov registry record · Phase 2
Trial of Adalimumab in Progressive Sarcoidosis
A Phase 2 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00311246: Clinical Trial Phase 2 study, sponsored by University of Chicago.
NCT00311246 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00311246, a Phase 2 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by the buildup of immune-system (fights off infection in the body) cells in organs. These cells form small groups called granulomas, which lead to inflammation of the surrounding tissue. Sarcoidosis most commonly affects the lung and the lymph nodes (part of the immune system). The signs usually include shortness of breath, fever, dry cough, and chest pain. Other signs in many patients can include redness and painful lumps on the skin, reduced eyesight, joint pain, and rarely, nervous system damage. Sarcoidosis commonly affects young and middle-aged adults. There are no approved therapies for the treatment of sarcoidosis. Corticosteroid (steroid hormone) therapy is considered the standard treatment. Only limited benefit has been shown when using corticosteroid therapy to ease lung symptoms or improve lung function in patients with sarcoidosis. Also, the effects of other therapies (for example: methotrexate, cyclophosphamide, anti-malarial drugs, thalidomide) and other immunosuppressants (drugs that suppress a body's natural defense system \[immune system\]) which have been used in a small number of patients are not well known and can cause long term problems. The drug used in this study is called adalimumab. Adalimumab is FDA (Food and Drug Administration) approved for patients with moderately to severely active rheumatoid arthritis. However, adalimumab is not approved for the treatment of sarcoidosis. Adalimumab is experimental in this study. The purpose of this study is to evaluate the safety and effectiveness of adalimumab in the treatment of patients with sarcoidosis with pulmonary (lung) involvement who show symptoms of the disease even though they are currently being treated with medication.
Primary Outcome
The forced vital capacity (FVC) measurement shows the amount of air a person can forcefully and quickly exhale after taking a deep breath. Improvement in FVC, if significant, means better breathing and lung function. The change in FVC done at screening and at week 24 were compared to notice if there were any changes.
Interventions
- DRUG Adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-04 |
| Est. Completion | 2008-09 |
| Phase | Phase 2 |
Why NCT00311246 stopped before completion
NCT00311246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Adalimumab is the first listed.
NCT00311246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00311246 about?
NCT00311246 is a clinical study titled "Trial of Adalimumab in Progressive Sarcoidosis". Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by the buildup of immune-system (fights off infection in the body) cells in organs. These cells form small groups called granulomas, which lead to inflammation of the surrounding tissue. Sarcoidosis most commonl...
What is the current status of trial NCT00311246?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2006-04. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00311246?
The interventions under investigation include: Adalimumab (DRUG).
Who is sponsoring clinical trial NCT00311246?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00311246's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03114462 · 11 participants · Phase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
- NCT06039709 · 11 participants · Phase 1
Sonodynamic Therapy in Patients With Recurrent GBM
- NCT06425380 · 11 participants · NA
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
- NCT06472661 · 11 participants · Early Phase 1
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia